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PROCESS SOLUTIONS
www.sph-group.com
SPH Group s.r.l., è in grado di fornire soluzioni completamente integrate nel campo
del processo farmaceutico, grazie alla multidisciplinarità delle proprie competenze.
Il Gruppo, vantando un’esperienza
pluriennale nel settore farmaceutico,
attraverso un aggiornamento continuo,
propone soluzioni tecniche in perfetta
armonia e rispetto delle GMP.
Nello specifico, SPH Group offre soluzioni
chiavi in mano nella fornitura dei seguenti
impianti ed equipment:
 Sale Soluzioni complete di linee
trasferimento prodotto;
 Impianti CIP/SIP (dedicati al lavaggio e
sterilizzazione liostati, serbatoi carrellati,
dissolutori, equipment vari);
 Linee di distribuzione WFI, PW, Vapore,
Aria compressa, Azoto;
 Dissolutori.
 SPH Group fornisce revamping completi sia dal punto di vista impiantistico che del
sistema di controllo.
 Le soluzioni tecniche proposte sono dotate di un proprio sistema di controllo e
supervisione SCADA (conforme con CFR21), e vengono sviluppate secondo le
esigenze del committente.
 Tutte le proposte impiantistiche possono essere realizzate sia come skid che come
impianti assemblati in loco.
 Ciascun progetto sarà accompagnato da uno studio preliminare e
modellizzazione dell’architettura impiantistica del cliente, così da poter proporre la
soluzione tecnica più appropriata ed integrata nel tessuto industriale in cui verrà
implementata.
SPH Group, partendo dall’esigenza impiantistica del cliente, lo supporta nell’intero
percorso che va dalla definizione delle User Requirement Specification di dettaglio,
alla costruzione dell’impianto/equipment, alla validazione dello stesso:
USER
REQUIREMENTS
SPECIFICATION
PROGETTAZIONE
MECCANICA COMMISSIONING START UP
REDAZIONE
DOCUMENTAZIONE PER
VALIDAZIONE :
 RISK ANALYSIS
 VALIDATION PLAN
 PROTOCOLLO IQ
 PROTOCOLLO OQ
 PROTOCOLLO PQ
VALIDAZIONE
La caratteristica distintiva di SPH Group è quella di fornire al committente un
interlocutore unico durante l’intera fase realizzativa del progetto, capace di
plasmare un impianto perfettamente in linea con le esigenze funzionali.
 FUNCTIONAL
SPECIFICATION
 SOFTWARE DESIGN
SPECIFICATION
 HARDWARE
DESIGN
SPECIFICATION
PROGETTAZIONE DI
PROCESSO
CONTATTI:
SPH GROUP S.r.l.
Via Aterno 80
66020 - San Giovanni Teatino (CH) - Italy
Tel/Fax 085 4972220 - P.IVA 02460450691
Web site: www.sph-group.com
email: info@sph-group.com
Sales Manager: Michele Lombardi
Cell: 340 7395368

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SPH Group Process Solutions

  • 2. SPH Group s.r.l., è in grado di fornire soluzioni completamente integrate nel campo del processo farmaceutico, grazie alla multidisciplinarità delle proprie competenze. Il Gruppo, vantando un’esperienza pluriennale nel settore farmaceutico, attraverso un aggiornamento continuo, propone soluzioni tecniche in perfetta armonia e rispetto delle GMP.
  • 3. Nello specifico, SPH Group offre soluzioni chiavi in mano nella fornitura dei seguenti impianti ed equipment:  Sale Soluzioni complete di linee trasferimento prodotto;  Impianti CIP/SIP (dedicati al lavaggio e sterilizzazione liostati, serbatoi carrellati, dissolutori, equipment vari);  Linee di distribuzione WFI, PW, Vapore, Aria compressa, Azoto;  Dissolutori.
  • 4.  SPH Group fornisce revamping completi sia dal punto di vista impiantistico che del sistema di controllo.  Le soluzioni tecniche proposte sono dotate di un proprio sistema di controllo e supervisione SCADA (conforme con CFR21), e vengono sviluppate secondo le esigenze del committente.  Tutte le proposte impiantistiche possono essere realizzate sia come skid che come impianti assemblati in loco.  Ciascun progetto sarà accompagnato da uno studio preliminare e modellizzazione dell’architettura impiantistica del cliente, così da poter proporre la soluzione tecnica più appropriata ed integrata nel tessuto industriale in cui verrà implementata.
  • 5. SPH Group, partendo dall’esigenza impiantistica del cliente, lo supporta nell’intero percorso che va dalla definizione delle User Requirement Specification di dettaglio, alla costruzione dell’impianto/equipment, alla validazione dello stesso: USER REQUIREMENTS SPECIFICATION PROGETTAZIONE MECCANICA COMMISSIONING START UP REDAZIONE DOCUMENTAZIONE PER VALIDAZIONE :  RISK ANALYSIS  VALIDATION PLAN  PROTOCOLLO IQ  PROTOCOLLO OQ  PROTOCOLLO PQ VALIDAZIONE La caratteristica distintiva di SPH Group è quella di fornire al committente un interlocutore unico durante l’intera fase realizzativa del progetto, capace di plasmare un impianto perfettamente in linea con le esigenze funzionali.  FUNCTIONAL SPECIFICATION  SOFTWARE DESIGN SPECIFICATION  HARDWARE DESIGN SPECIFICATION PROGETTAZIONE DI PROCESSO
  • 6. CONTATTI: SPH GROUP S.r.l. Via Aterno 80 66020 - San Giovanni Teatino (CH) - Italy Tel/Fax 085 4972220 - P.IVA 02460450691 Web site: www.sph-group.com email: info@sph-group.com Sales Manager: Michele Lombardi Cell: 340 7395368